FDA Product Code
FDA Product Code FLF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6860
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2017-10-31 | Traditional | PDF ↗ |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2015-11-18 | Traditional | PDF ↗ |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | 2015-01-08 | Abbreviated | PDF ↗ |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2009-12-02 | Traditional | PDF ↗ |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2006-07-26 | Traditional | PDF ↗ |
| K020875 | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 | Traditional | PDF ↗ |
| K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | 2003-06-25 | Abbreviated | PDF ↗ |
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | Advanced Sterilization Products | 2003-04-03 | Traditional | PDF ↗ |
| K905119 | PLAZLYTE(TM) | Abtox, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K923442 | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | 1994-12-02 | Traditional | PDF ↗ |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | 1994-02-07 | Traditional | PDF ↗ |
| K915682 | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | 1991-09-06 | Traditional | PDF ↗ |
| K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Joslyn Valve Corp. | 1991-03-07 | Traditional | PDF ↗ |
| K902036 | STERI-VAC GAS STERILIZER MODEL 5XL | 3M Company | 1990-07-19 | Traditional | PDF ↗ |
| K873200 | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | 1989-01-27 | Traditional | PDF ↗ |
| K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II | Ben Venue Laboratories, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Amsco Co. | 1983-10-19 | Traditional | PDF ↗ |
| K821842 | GAS STERILIZATION EQUIPMENT | Getinge International, Inc. | 1982-07-28 | Traditional | PDF ↗ |
| K820783 | CASTLE MICROCOMPUTER STERILIZER CONTROL | Sybron Corp. | 1982-04-15 | Traditional | PDF ↗ |
| K812867 | STERI-VAC #400C GAS STERILIZER | 3M Company | 1981-11-02 | Traditional | PDF ↗ |
| K792660 | 1500 EO EXHAUST HOOD | Castle Co. | 1980-01-29 | Traditional | PDF ↗ |
Product code FLF · Class II · General Hospital. Data: openFDA.